Systems and methods for aneurysm treatment and vessel occlusion

ABSTRACT

A system for treating an aneurysm includes an expandable barrier positionable to bridge an aneurysm neck. The barrier may comprise a fiber mesh, a balloon or a molly anchor member, and may unroll, unfold, or inflate from a compact configuration to an expanded configuration. Expansion of the barrier may be greater radially than axially. A vaso-occlusive member comprising a coil or balloon may be deposited in the aneurysm. Another aneurysm treatment system comprises an outer fenestrated stent and/or an inner fenestrated sleeve, which may be implanted together adjacent an aneurysm neck to regulate blood flow to the aneurysm. The sleeve may be movable relative to the stent to open or occlude the fenestrations, which may vary in size, shape, and distribution. An intra-luminal vessel occlusion device comprises a stent and a sheath. A drawstring may be actuated to gradually close a sheath orifice to control blood flow through the vessel.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of:

pending U.S. patent application Ser. No. 12/582,052, filed Oct. 20,2009, which carries Applicants' docket no. DUG-2, and is entitledSYSTEMS AND METHODS FOR ANEURYSM TREATMENT AND VESSEL OCCLUSION, whichclaims the benefit of:

U.S. Provisional Patent Application No. 61/106,670, filed Oct. 20, 2008,which carries Applicants' docket no. DUG-2 PROV, and is entitled DEVICESAND METHODS FOR ANEURYSM TREATMENT; and

U.S. Provisional Patent Application No. 61/172,856, filed Apr. 27, 2009,which carries Applicants' docket no. DUG-4 PROV, and is entitled DEVICESAND METHODS FOR ANEURYSM TREATMENT.

The above-identified documents are incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. The Field of the Invention

The invention relates to endovascular medicine, and more particularly,to systems and methods for aneurysm treatment and selective vesselocclusion.

2. The Relevant Technology

Cerebrovascular disease encompasses a broad spectrum of disorders,including intracranial aneurysms. Unruptured intracranial aneurysms havea prevalence of approximately 3.6 to 6% in the U.S. population and havean estimated annual rate of rupture between 10-28 per 100,000. Mostindividuals with aneurysms remain asymptomatic. Multiple risk factorsfor the development of intracranial aneurysms include: smoking,hypertension, positive family history and cocaine use. A number ofinherited disorders have also been associated with the development ofintracranial aneurysms. Ruptured intracranial aneurysms are the mostcommon cause of non-traumatic subarachnoid hemorrhage (SAH). SAHsecondary to aneurysm rupture is a potentially lethal event and carriesa 50% morbidity-mortality rate.

An aneurysm is an abnormal localized dilation of a vessel. Aneurysmsmost frequently occur at sites of arterial bifurcation and are mostcommonly found in the brain. Pathologically, aneurysms have an absent orfragmented internal elastic membrane. Intracranial aneurysms areclassified as saccular, fusiform, dissecting or false. Approximately 90%of intracranial aneurysms are saccular and are described by size,contour, orientation, location and neck size. Select unruptured and allruptured intracranial aneurysms require either surgical or endovascularintervention.

Surgical intervention had long been the gold standard of care for themanagement of intracranial aneurysms and involves the placement of aclip across the aneurysm neck. A recent meta-analysis reviewing therisks of surgical repair found an overall mortality rate of 2.6 percentand a permanent morbidity rate of 10.9 percent. Endovascular treatmentof intracranial aneurysms has developed over the last two decades. Theprocedure most commonly involves the insertion of a “coil” of wire intothe aneurysm. The coil is delivered to the aneurysm through catheters,which are placed and guided through arteries. The Guglielmi DetachableCoil (GDC) pioneered the field of endovascular treatment of intracranialaneurysms and involved electrolytic detachable platinum coils that wereplaced directly into the fundus of the aneurysm via a microcatheter anddetached from a stainless-steel micro-guidewire by an electricalcurrent. Studies suggest that endovascular treatment may be associatedwith less procedural morbidity and mortality than conventional surgicaltechniques as well as reduced recovery time and earlier return to normalfunctioning.

Although endovascular techniques have created a paradigm shift in themanagement of intracranial aneurysms, the technique still has manylimitations. This is particularly evident in the treatment ofwide-necked, dissecting and fusiform aneurysms. Until recently,wide-necked aneurysms (defined as an aneurysm with a neck width >4 mmand/or a fundus/neck ratio <2) were not considered amenable toendovascular coiling for fear that a coil may prolapse into the parentvessel, leading to altered flow dynamics and stroke. More recently,expandable stents have been placed in the parent vessel—acting as ascaffold across the neck of the aneurysm, to prevent coil prolapse. Forwide neck aneurysms, this has held promise in preventing coil migration.The introduction of the flexible intracranial stent (Neuroform; BostonScientific) improved the management of these complex intracranialaneurysms, but was associated stent migration/misplacement anddifficulties in coil delivery. In this system, the coils are insertedinto the aneurysm dome via the fenestrations in the stent. Thelimitation with this design is that the fenestrations still allow bloodto enter the aneurysm. Thus this strategy depends on the delivery ofcoils to occlude the dome. The introduction of the coils through thefenestrations in the stent can be associated with dislodgement/migrationof the stent during the coiling. More recently, to avoid this problem,intracranial balloons have been used in conjunction with coils andstents. In this technique, the balloon is first inserted into the parentvessel, distal to the aneurysm. Once in place, the balloon is inflated,occluding distal blood flow. During this temporary occlusion, the coilsare then inserted and are placed in the dome of the aneurysm. Duringthis process, the balloon is intermittently inflated and deflated—in anattempt to prevent distal ischemia. Finally, once the coiling of theaneurysm is complete, a stent is placed across the neck of the aneurysmto prevent coil prolapse. The balloon is then deflated and distal bloodflow resumed.

More recently, further advances have been made for the endovasculartreatment of intracranial aneurysms using flow-diversion principlesinstead of space-occupying principles such as endovascular coiling. Oneof these devices, the JOSTENT (Abbott), is comprised of an expandablePTFE barrier between two stainless steel stents. Accordingly, it doesnot have fenestrations and has been used to extensively in cardiacendovascular procedures. This stent is placed in the parent vessel suchthat it directly occludes the neck of the aneurysm and prevents flowinto the aneurysm. Unfortunately, this has had limited applications inthe cranial vasculature, as its design is inflexible and difficult toposition. In addition, its geometry poses a risk for occlusion ofperforating vessels that may be in the vicinity of the aneurysm neck.Another flow-diversion device, the Pipeline Embolization Device (eV3),has been successful in decreasing blood flow into the aneurysm, whilemaintaining the patency of surrounding branch vessels. The Pipeline is aself-expanding cylindrical braided mesh construct that has decreasedporosity size along the entire length of the stent which occludes theneck of the aneurysm. The cells of the mesh are sufficient to embolizethe aneurysm while maintaining patency of the parent artery andminimizing disruption to flow into perforating vessels near theaneurysm.

The modern era of aneurysm treatment began with Hunterian ligation ofthe parent vessel. With increasing sophistication of surgical andendovascular management techniques, the indications for vessel occlusionfor management of complex aneurysms are limited. A number of strategieshave been devised for arterial occlusion including the Selverstoneclamp, a device that allowed for gradual occlusion of the vessel. Therationale for gradual occlusion of the vessel was to promote thecapacity for collateral circulation of the circle of Willis, in the hopeof preventing post-occlusion cerebral infarction. This device could bereopened at the first sign of cerebral ischemia secondary toinsufficient collateral circulation. A number of subsequent devices allincorporated an external mechanism that allowed the surgeon to graduallydecrease the caliber of the vessel until ultimately achieving completeocclusion. In complex vascular disorders, deemed untreatable by bothdirect surgical or endovascular techniques, a test occlusion by balloonis performed by endovascular techniques. Unfortunately this does notprovide a gradual occlusion of the vessel and does not allow for thegradual development of collateral circulation. At present, noendovascular technique allows for the gradual occlusion of a vessel.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present invention will now be discussed withreference to the appended drawings. It is appreciated that thesedrawings depict only typical embodiments of the invention and aretherefore not to be considered limiting of its scope.

FIG. 1 is a stylized perspective side view of a representativewide-necked aneurysm of a parent blood vessel;

FIG. 2A is a partial cross-sectional side view of the aneurysm of FIG. 1with a stent in the parent vessel and a barrier across the aneurysmneck;

FIG. 2B is a side view of the stent and barrier of FIG. 2A with thebarrier in a curved configuration;

FIG. 3A is a top view of the barrier of FIG. 2A;

FIG. 3B is a cross-sectional side view of the barrier of FIG. 3A, takenalong line B-B;

FIG. 4 is a partial cross-sectional side view of the aneurysm, stent andbarrier of FIG. 2A and a vaso-occlusive coil in the aneurysm;

FIG. 5A is a partial cross-sectional side view of the aneurysm, stentand barrier of FIG. 2A and a vaso-occlusive elliptical balloon in theaneurysm;

FIG. 5B is a partial cross-sectional side view of the aneurysm, stentand barrier of FIG. 2A and a vaso-occlusive conical balloon in theaneurysm;

FIG. 6A is a top view of a sleeve with a cutout window;

FIG. 6B is a side view of the sleeve of FIG. 6A;

FIG. 6C is a top view of a stent with a cutout window;

FIG. 7A is a partial cross-sectional view of an aneurysm with the sleeveof FIG. 6A inside the stent of FIG. 6C, the sleeve and stent juxtaposedto provide an open window and open stent cells, and a vaso-occlusivecoil;

FIG. 7B is a partial cross-sectional view of the aneurysm, sleeve, stentand coil of FIG. 7A, with the sleeve rotated relative to the coil toprovide a closed window and occluded stent cells;

FIG. 7C is a cross-sectional view of the sleeve and stent of FIG. 7Ataken at line C-C, showing an angle of the open window;

FIG. 8A is a side view of a stent with fenestrations;

FIG. 8B is a side view of a sleeve with fenestrations;

FIG. 8C is a side view of a sleeve with fenestration zones;

FIG. 8D is a side view of a sleeve with fine fenestrations;

FIG. 8E is a side view of a sleeve with two zones of round fenestrationsand one zone of vent-like fenestrations;

FIG. 8F is a side view of a sleeve with two zones of round fenestrationsand one zone of finer round fenestrations;

FIG. 9A is a side view of the sleeve of FIG. 8C inside the stent of FIG.8A, the sleeve and stent juxtaposed to provide open stent cells in acentral zone and occluded stent cells in two flanking zones;

FIG. 9B is a side view of the sleeve and stent of FIG. 9A, the sleeveand stent juxtaposed to provide occluded stent cells in the central zoneand occluded stent cells in the two flanking zones;

FIG. 10A is a partial cross-sectional view of the aneurysm, coil, sleeveand stent with cutout windows of FIG. 7A, and a microcatheter depositingan expandable molly anchor barrier into the aneurysm;

FIG. 10B is a partial cross-sectional view of the aneurysm, coil,sleeve, stent and molly anchor barrier of FIG. 10A, with the barrierexpanded across the neck of the aneurysm;

FIG. 10C is a cross-sectional view of the molly anchor barrier of FIG.10B;

FIG. 11 is a partial cross-sectional view of an aneurysm with a coil inthe aneurysm and a sleeve inside a stent in the vessel adjacent theaneurysm, the stent having a barrier formed on the stent;

FIG. 12A is a side view of the sleeve of FIG. 8E;

FIG. 12B is a perspective cross-sectional view of the sleeve of FIG.12A, taken at line B-B;

FIG. 12C is an end cross-sectional view of the sleeve of FIG. 12A, takenat line B-B, showing inner flaps of the vents;

FIG. 13A is a perspective view of a stent comprising a window havingpivotable flaps which are selectively actuable to open or close;

FIG. 13B is a cross-sectional view of the stent of FIG. 17A taken atline B-B, the stent in a compact configuration;

FIG. 13C is a cross-sectional view of the stent of FIG. 17A taken atline B-B, the stent in an expanded configuration;

FIG. 14A is a detail view of the window of FIG. 17A, with the flaps inan open position;

FIG. 14B is a detail view of the window of FIG. 17A, with the flaps in aclosed position;

FIG. 15A is a side view of a intra-luminal occlusion device comprising astent, a sheath and a drawstring;

FIG. 15B is a cross-sectional side view of the intra-luminal occlusiondevice of FIG. 15A, with a sheath orifice in an open configuration;

FIG. 15C is a cross-sectional side view of the intra-luminal occlusiondevice of FIG. 15A, with a sheath orifice in an partially openconfiguration;

FIG. 15D is a cross-sectional side view of the intra-luminal occlusiondevice of FIG. 15A, with a sheath orifice in a closed configuration;

FIG. 16 is a side view of an alternate embodiment of an intra-luminalocclusion device with a sheath orifice in a partially openconfiguration;

FIG. 17A is a partial cross-sectional view of an aneurysm with twostents in the vessel adjacent the aneurysm, and a half-pipe connectionmesh bridging the aneurysm and connecting the two stents;

FIG. 17B is a partial cross-sectional view of an aneurysm with twostents in the vessel adjacent the aneurysm, and a cylindrical connectionmesh bridging the aneurysm and connecting the two stents; and

FIG. 18 is a partial cross-sectional view of a basilar tip aneurysm,with two stents in adjacent branching vessels and a connection meshbridging the aneurysm and connecting the two stents, and a third stentin a main vessel.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention relates to systems and methods for providinganeurysm treatment, and selective vessel occlusion. Those of skill inthe art will recognize that the following description is merelyillustrative of the principles of the invention, which may be applied invarious ways to provide many different alternative embodiments. Thisdescription is made for the purpose of illustrating the generalprinciples of this invention and is not meant to limit the inventiveconcepts in the appended claims.

Complex intracranial aneurysm treatment requires techniques formanagement of wide neck aneurysms, and for gradual occlusion of theparent vessel. Systems and methods disclosed herein provide a stent withan opening that could ultimately be open or closed, allowing theradiologist/surgeon to deploy coils or other various agents in acontrolled and reliable manner. A number of these methods canincorporate an “open-closed window” technique. In at least one approach,the stent contains an opening, or aperture, that would allow thedeployment of coils or other devices into the dome of the aneurysm(“open window”). Once occlusion of the aneurysm had been completed, theaperture would be closed—preventing dislodgement or prolapse of thecoils (“closed window”). A mechanical means of controlling the apertureof a lumen within the body of a stent could be applied to all existingand future stents and could also be adapted to provide a means ofgradual occlusion of a vessel.

In another approach, a stent comprises a plurality of apertures orcells, and an inner sleeve disposed within the stent similarly comprisesa plurality of apertures or cells. By changing the juxtaposition of thesleeve relative to the stent by rotation and/or translation, allowingthe stent cells to overlay the sleeve cells, the permeability of thestent can be varied.

Previously, wide neck aneurysms have been typically deemed “uncoilable”and instead required an open surgical approach. One approach disclosedherein utilizes a sleeve either inside or outside of the stent. Thesleeve may have several wide openings in it as well as a closed (noopenings) component. The sleeve may have a preconfigured curvatureallowing it to bridge across the lumen of the vessel. To gain access tothe aneurysm, the open segment of the sleeve may be positioned such thataccess to the neck of the aneurysm is provided. The opening in thesleeve may span across the lumen of the vessel, allowing for normalblood flow during the coiling of the aneurysm. The closed segment ofsleeve may be positioned on the contralateral side of the vessel, thusleaving perforating vessels perfused. Once the coiling of the vessel iscompleted, the sleeve may then be retracted such that the “closed”segment is positioned at the neck of the aneurysm. By now closing accessto the neck of the aneurysm, prolapse of coils or other agents may beprevented. This may also eliminate any further significant blood flowinto the aneurysm. Alternatively, the closed segment of the sleeve maybe positioned in such a manner as to occlude blood flow through theblood vessel during the coiling. Once coiling is complete, the sleevecould then be retracted to a “closed” position, occluding the opening(window) in the stent and preventing any further significant blood flowinto the aneurysm.

Referring to FIG. 1, a stylized perspective view of a representativewide-necked aneurysm is shown. Parent vessel 2 defines a vessel lumen 4having a substantially cylindrical lumen wall 6. An aneurysm 8 protrudesfrom the lumen wall 6, comprising an aneurysm sac 10 which joins thewall at an aneurysm neck 12. A branching vessel 14 branches from theparent vessel near the aneurysm.

Referring to FIG. 2A, a cutaway view of parent vessel 2 and aneurysm 8is shown, with a stent 20 in the vessel lumen 4 and a barrier 30implanted to extend across the aneurysm neck 12, forming an aneurysmtreatment system. The stent 20 may be a fenestrated stent known in theart, and comprises a first end 22, a second end 24, and a stent wall 26which defines a stent lumen 28. The stent wall comprises plurality offenestrations, or cells 29, allowing flexibility of the stent, andallowing blood flow through the stent wall. The stent may be made tohave anti-thrombogenic properties on the inner surface and thrombogenicproperties on the exterior surface. Barrier 30 includes a first, orouter side 32 which may be also be coated or treated with a thrombogenictreatment, and a second, or inner side 34 which may be coated or treatedwith an anti-thrombogenic treatment. In some embodiments, an opening 36may communicate with the first and second sides 32, 34. The opening 36may engage with an instrument for implantation, deployment and/orexpansion of the barrier.

The barrier 30 may serve as a shield or blanket to slow or prevent bloodflow into the aneurysm, providing an environment for spontaneousthrombosis of the aneurysm and/or provide support at the aneurysm neckto prevent prolapse of coils or other intra-saccular aneurysm implantsinto the parent vessel. Barrier 30 may be delivered before, in tandemwith, or after placement of the stent. The barrier 30 may be rolled,coiled up, folded, deflated, compressed, or otherwise retracted to forma compact configuration, and it may be deployed or expanded to form anexpanded configuration. The barrier may be delivered to the aneurysmthrough the stent wall 26 in the compact configuration, then unrolled,uncoiled, unfolded, inflated, uncompressed or otherwise expanded to formthe expanded configuration like that seen in FIG. 2A. The barrier mayextend substantially across the aneurysm neck, in which the barrierblocks the opening between the aneurysm and the vessel to minimize orentirely prevent bloodflow between the aneurysm and the vessel, yet doesnot touch the neck, in order to prevent rupture of the aneurysm. Thebarrier may also be delivered alongside the stent, passing between thestent wall 26 and the vessel lumen wall. A microcatheter may deliver thebarrier to the aneurysm before delivery of the stent, or through oralongside the stent after delivery of the stent. In some embodiments,the barrier is formed as a patch on a portion of the stent wall 26.

FIG. 2B depicts the barrier 30 and the stent 20, with the barrier in acurved configuration. This configuration may allow the barrier to morecompletely shield the aneurysm neck to prevent blood flow from thevessel into the aneurysm.

FIG. 3A depicts a top view of barrier 30, and FIG. 3B is an enlargedcross-sectional lateral view taken along section line B. Barrier 30 maybe a single, solid member, or may have an interior space 38 formedbetween the first and second sides 32, 34. When the barrier is expandedor inflated, a volume of the interior space may increase; when thebarrier is retracted or deflated, the volume may decrease. The barriermay expand or contract laterally, increasing or decreasing in radius rrelative to a longitudinal axis 39, which may also be referred to asradial expansion. It may also expand or contract axially, increasing ordecreasing in height h. In some embodiments, radial expansion of thebarrier may be greater than axial expansion. Barrier 30 may be comprisedof materials including nylon, polypropylene, polyester, polyurethane,polyvinyl chloride, Teflon, ePTFE, PTFE, polyethylene, polypropylene,silicone, PEEK, and/or hydrogel, among others. These materials may takethe form of a fabric, or fiber mesh in which the fibers are woven,knitted, coiled, braided or otherwise intermeshed together. A meshbarrier may have an interior space formed between the outer strands ofthe mesh. In an alternative embodiment, the barrier may comprise beads,in which each individual bead is larger in diameter than the maximumwidth of a stent cell 29, preventing passage of the beads through thestent cells. Such beads may comprise hydrogel, and swell to enlarge whendeposited in the aneurysm sac and exposed to fluid. The barrier may besymmetrical axially and radially as shown in FIGS. 3A and 3B, or it maybe asymmetrical in any direction.

An intra-saccular vaso-occlusive member may be included in the aneurysmtreatment system. Referring to FIG. 4, a vaso-occlusive membercomprising a coil 40 is shown implanted in the aneurysm sac; the barrier30 prevents the coil 40 from penetrating the stent 20 and/or escapingthe aneurysm through the aneurysm neck 12. The coil 40 may comprise oneor a plurality of coil members, and may be a coil known in the art.Implantation of the coil may occur prior to, with, or after implantationof the barrier. A coil introduction instrument comprising amicrocatheter carrying the coil may be advanced through the stent lumen24, through the stent wall 26 and through the barrier opening 36, andthe coil deposited from the microcatheter into the aneurysm sac 10.Alternatively, the microcatheter may be advanced alongside the stent andthrough the aneurysm neck 12, and the coil deposited into the aneurysmsac. The coil introduction instrument may further comprise a shieldlocated proximal to the microcatheter tip, the shield positionable tobridge the aneurysm neck as the coil is introduced into the aneurysm,preventing migration of the coil out of the aneurysm sac.

In some embodiments, a vaso-occlusive member may comprise a gel and/orfoam scaffold which is injected into the aneurysm under low pressure,after placement of a barrier in the aneurysm neck. A microcatheter tipis inserted through an opening such as barrier opening 36, and the gelor foam is injected into the aneurysm sac. Following insertion, thematerial may solidify and bind together.

In another embodiment, the vaso-occlusive member may comprise a softtextile coil impregnated with a clotting agent. This type of coil may beimplanted through the wall of a stent, but without a barrier. Afterimplantation of the coil, blood is allowed to flow into the aneurysmthrough the stent, and the clotting agent on the coil is activated bythe blood to bind the coil to itself, using blood as the binding agent.

Referring to FIGS. 5A and 5B, a vaso-occlusive member comprising aballoon may be implanted in the aneurysm. A vaso-occlusive balloon maycomprise an elastomeric sheath comprising silicone, polyurethane, orhydrogel, among other material. The balloon may comprise an ellipticalshape as depicted, a round shape, a conical shape, or a ring or donutshape with a central opening, among others. FIG. 5A depicts a roundballoon 50 comprising an elastomeric sheath 52, while 5B depicts anosecone balloon 54 comprising an elastomeric sheath 54 with a pluralityof zones. A nipple or other port may be included for balloon inflationand/or deflation. The elastomeric sheath may comprise a compliantmaterial with a uniform level of compliance or elasticity. In otherembodiments, the elastomeric sheath may comprise zones with varyinglevels of compliance or elasticity, such that the balloon inflates to agreater extent in some zones than in others. For example, the balloonmay inflate to a greater extent radially than axially, in order to moreeffectively obscure the neck of the aneurysm. The balloon may also bepre-shaped to inflate to a specific predetermined shape, such as thosepreviously listed.

It is appreciated that the vaso-occlusive balloon may be implanted withor without a barrier such as barrier 30, and it may be implanted before,with, or after the barrier. The balloon may be implanted using themethods disclosed previously for implantation of a coil. A microcathetermay be actuated to implant the balloon into the aneurysm through oralongside the stent, and a microcatheter may also deliver fluid into theballoon to inflate the balloon. The barrier opening 36 may allow passageof the microcatheter to the balloon. Suitable fluids for inflation mayinclude air, saline solution, hydrogel, silicone, polyvinyl acetate(PVA), and curable adhesives, among others.

Another approach to occluding an aneurysm comprises a first stent, and asecond stent or sleeve which may be deployed inside or outside thestent. The stent and sleeve may be rotated and/or axially translatedrelative to one another to provide an open or closed window to theaneurysm, and to provide varying degrees of blood flow through the stentand sleeve walls. FIGS. 6A and 6B depict a sleeve 60 comprising a firstend 62, a second end 64, and a stent wall 66 which defines a sleevelumen 67. The sleeve wall comprises plurality of fenestrations, orsleeve cells 69, allowing flexibility of the sleeve, and allowing bloodflow through the sleeve wall. A sleeve window 68 is located in thesleeve wall. Depicted in FIG. 6C, stent 70 comprises a first end 72, asecond end 74, and a stent wall 76 which defines a stent lumen 77. Thestent wall comprises plurality of fenestrations, or stent cells 79,allowing flexibility of the stent, and allowing blood flow through thestent wall. A stent window 78 is located in the stent wall. As seen inFIGS. 6A-6C, window 68 may be smaller than window 78; in otherembodiments, window 68 may be larger than window 78, or they may be thesame size. When sleeve 60 is disposed within stent 70, sleeve 60 and/orstent 70 may be rotated and/or translated relative to one another toallow windows 68, 78 to line up to allow passage of blood,vaso-occlusive members or other bodies through the windows. Similarly,the sleeve cells 69 and stent cells 79 may be partially or fully linedup to allow maximal blood flow through the sleeve and stent walls 66,76, or partially or completely occlude blood flow through the sleeve andstent walls. Sleeve 60 may also be disposed outside of stent 70. Thesleeve and stent windows 68, 78 may be rectangular as depicted in FIGS.6A-6C, or they may be round, oval, or any other shape.

FIGS. 7A and 7B depict stent 70 and sleeve 60 placed in a vesseladjacent aneurysm 8. In FIG. 7A, sleeve 60 and stent 70 are juxtaposedso that window 68 and 78 are lined up, creating an unimpeded openingbetween the aneurysm 8 and the lumen of the sleeve. Coil 40, or otherintra-saccular materials as desired, may be implanted in the aneurysmwhen the sleeve and stent are in this “open” configuration. FIG. 7Bdepicts sleeve 60 and stent 70 in a “closed” configuration, in whichsleeve 60 has been rotated so that sleeve window 68 is no longer linedup with stent window 78. In the “closed” position, coil 40 cannot passout through the windows, and blood flow may be impeded. FIG. 7C is anend cross-sectional view of the sleeve and stent in the “open”configuration of FIG. 7A.

The window dimensions may vary in length and width. Preferably, thewindow widths may range from 10° to 180° of the circumference of therespective sleeve or stent. More preferably, the window width rangesfrom 30° to 60° of the circumference of the respective sleeve or stent.In an exemplary embodiment, the window width is 45° of the circumferenceof the respective sleeve or stent. In the embodiment depicted in FIG.7C, both stent 70 and sleeve 60 have a window width which is subtendedby angle a of approximately 40°.

In another embodiment of the invention, blood flow to an aneurysm may bedecreased or entirely occluded by a device comprising an outer stent andan inner stent or sleeve, placed in the vessel adjacent the aneurysm.The outer stent may have fenestrations or cells of regular size anddistribution, while the inner sleeve may have fenestrations or cells ofdiffering sizes which may be distributed regularly or within zones. Whenthe inner sleeve is disposed in the outer stent and rotated and/ortranslated relative to the outer sleeve, the overlay of the outer stentrelative to the inner sleeve can increase or decrease effective outerstent cell sizes to change the permeability of the stent wall to bloodflow. Changing the effective outer stent cell size may increase,decrease or occlude flow to the aneurysm.

Referring to FIGS. 8A through 8F, several embodiments of outer stent andinner sleeve configurations are shown. FIG. 8A depicts flexible stent70, comprising quadrilateral fenestrations 72. FIG. 8B depicts sleeve80, comprising substantially round fenestrations 82. When sleeve 80 isdisposed in stent 70, the sleeve fenestrations 82 may line up with thestent fenestrations 72 similar to FIG. 7A, in which each sleevefenestration is lined up with a stent fenestration to create relativelyunimpeded openings. Sleeve 80 may be rotated relative to stent 70 sothat the fenestrations no longer line up in an open fashion, similar toFIG. 7B. In this configuration, blood flow would be impeded incomparison to the configuration in FIG. 7A.

FIG. 8C depicts sleeve 90, which has sleeve fenestrations 92 distributedin three zones. Two first zones 94 have fenestrations distributed incircumferential rows, while in second zone 96, the rows of fenestrationsare offset from those in zones 94. Zones 94 and 96 are circumferential;however it is appreciated that in other embodiments the zones could bearranged longitudinally along the length of the sleeve.

FIG. 8D depicts sleeve 100 having fenestrations 102. Sleevefenestrations 102 are relatively smaller than those in the other sleeveembodiments. When sleeve 100 disposed in stent 70, together they maycreate a device with relatively less blood flow permeability than thatof the other embodiments depicted.

FIG. 8E depicts a sleeve 110 having first zones 114 comprising roundfenestrations 112, and second zone 116 has slot-like or vertical vents118. Each vent comprises a flap which may be open when there is no bloodor fluid flow through the lumen of the sleeve, and closed by fluidpressure when blood flows through the lumen.

FIG. 8F depicts a sleeve 120 having two zones 124 with largefenestrations 122, while zone 126 has relatively finer fenestrations128.

Any of the sleeves disclosed in FIGS. 8B-8F may be combined with stent70 or another stent to form aneurysm treatment devices with varyingpermeability to fluids. As described, the sleeve and/or stent may berotated and/or translated relative to one another to create open,partially open, or closed cells. Additionally, a stent may comprise anyof the cell or fenestration configurations and distributions disclosedherein. Other methods of affecting cell size or opening can includefluid pressure, or using radio frequency (RF) or ultrasonic energy tochange cell sizes in specifically zoned portions of a stent and/orsleeve in situ. For example, an ultrasonic energy delivery device maycomprise a guidewire through which ultrasound is passed. In anotherembodiment, a stent and sleeve combination may have an integrally formedzone of compliance that is activated by axially stretching orcompressing the stent and sleeve. In other embodiments, the stent andsleeve may be coupled or fused together during manufacture. The stentsand sleeves disclosed herein may be implanted with or without avaso-occlusive member such as a coil or balloon, and with or without abarrier member.

Referring to FIGS. 9A and 9B, occlusion device 130 comprises outer stent70 and inner sleeve 90. Three zones are distributed circumferentiallyabout the device; two zones 134 adjacent first and second ends of thedevice, and zone 136 substantially centrally located. The occlusiondevice 130 comprises an open configuration as seen in FIG. 9A, in whichthe sleeve 90 and stent 70 are juxtaposed to form open fenestrations 135in the central zone 136. End zones 134 comprise closed fenestrations137. In FIG. 9B the sleeve 90 has been rotated relative to the stent 70to create a closed configuration, in which central zone comprises closedfenestrations 137. When implanted in a vessel so that an aneurysm isadjacent central zone 136, blood flow to the aneurysm may be allowedwhen the device is in the open configuration depicted in FIG. 9A, andblood flow may be occluded when the device is in the closedconfiguration depicted in FIG. 9B. Of course, the sleeve 90 may bepartially rotated relative to the stent 70 to cause partial occlusion.Also, if desired, a coil 40 or other vaso-occlusive member may beimplanted in the aneurysm sac before or after placement of occlusiondevice 130.

An aneurysm treatment comprising a barrier and a vaso-occlusive devicemay be implanted in conjunction with an outer stent and inner sleevedevice such as those disclosed in FIGS. 6-9. Referring to FIG. 10A, alongitudinal cross-section of a vessel 2 with an aneurysm 8 is shown.Outer stent 70 and inner sleeve 60 have been introduced into the vesseland juxtaposed so that windows 68, 78 are aligned to create an openinginto the aneurysm. A microcatheter 142 is inserted into the inner sleevelumen and a microcatheter tip 142 protrudes through the open windows 68,78. A coil 40 has been introduced into the aneurysm, and an expandablebarrier 150 comprising a molly anchor is projecting out of themicrocatheter tip. In FIG. 10B, the expandable barrier 150 has beendeposited into the aneurysm neck and is expanded. Inner sleeve 60 hasbeen translated relative to outer stent 70 to close the opening into theaneurysm. In FIG. 10C, a cross-sectional view of the expandable barrier150 shows a central stem 152, an upper or outer side 154, and a lower orinner side 156. Outer side 154 is coupled to stem 152 and stem 152 isslidable relative to inner side 156. Thus, expandable barrier 150 cancollapse and deploy like an umbrella. In FIG. 10A, expandable barrier150 is in a retracted or compact configuration, and in an expandedconfiguration in FIG. 10B. In some embodiments, coil 40 may be coupledto expandable barrier 150 to be deployed with the barrier; or they maybe implanted separately. In another embodiment, the molly anchor barriermay be implanted without a coil.

The molly anchor type barrier may comprise wire including Nitinol, wiremesh, an elastomeric sheath, fabric, or other materials previouslylisted. In addition, the molly anchor barrier may comprise hydrogel, sothat it enlarges in size once implanted and exposed to fluid. In otherembodiments, a coil may be formed integrally with, or connected to, amesh or fabric skirt. Following insertion of the coil into the aneurysm,the attached skirt is deposited into the aneurysm neck and unrolls orunfolds to form a barrier to occlude the aneurysm neck, and preventescape or migration of the coil into the vessel.

Referring to FIG. 11, an alternative embodiment of an occlusion devicecomprises an inner sleeve, a coil, and a barrier formed on an outerstent and implanted into a vessel to occlude blood flow into ananeurysm. Stent 160 comprises a flexible, expandable stent with abarrier patch 162 formed on a portion of the stent wall. Stent 160 maybe placed in the vessel with inner sleeve 60 positioned in the stentlumen. The sleeve 60 and stent 160 may be juxtaposed relative to oneanother so that the patch 162 is not occluding the aneurysm neck, andcoil 40 is deposited by a microcatheter through the open cells of sleeve60 and stent 160. After deposition of the coil into the aneurysm, stent160 may be rotated relative to the coil until the patch 162 covers theaneurysm neck. Alternatively, the coil may be inserted along the outersurface of the stent; or, the stent may be installed after deposition ofthe coil in the aneurysm sac. The patch 162 may be entirely occlusive toblood flow, or have a greater degree of permeability. The patch 162 maycomprise materials including nylon, polypropylene, polyester,polyurethane, polyvinyl chloride, Teflon, ePTFE, PTFE, polyethylene,polypropylene, silicone, PEEK, and/or hydrogel, among others. The patchmay be made to have anti-thrombogenic properties on the inner surfaceand thrombogenic properties on the exterior surface. In an alternativeembodiment, stent 160 having a barrier patch 162, and a coil or otherintra-saccular device may be deployed without inner sleeve 60.

FIGS. 12A-12C shows sleeve 110 in greater detail. Sleeve 110 comprisesat least one zone 116 which has a plurality of slot-like fenestrations118 arrayed transverse to the longitudinal axis of the sleeve. Adjacenteach fenestration 118 on an inner side 117 of the sleeve wall is a flap119. When no pressure is applied through the lumen of the sleeve, theflaps 119 project radially inward, so that the vent-like fenestrations118 are open. When fluid pressure is applied through the lumen, thepressure closes the flaps 119 so that they are substantially parallel tothe inner side of the sleeve, covering and closing the fenestrations118. If a sleeve 110 is placed in a vessel so that second zone 116 isadjacent an aneurysm neck and blood is allowed to flow through thesleeve, the flaps 119 will be held closed by the blood flow, preventingflow into the aneurysm. If the second zone 116 overlaps any branchingvessels, perpendicular flow should open the flaps to minimize disruptionof flow to those vessels. The round fenestrations 112 in zones 114 mayalso allow blood flow to adjacent branching vessels in those zones. Theflaps 119 may comprise a polyurethane film or equivalent. Sleeve 110 maybe used by itself, formed into a stent such as stent 70, or used with astent such as stent 70. Zone 116 may be circumferential as in FIGS.12A-12C, or may occupy a round, rectangular or other shaped portion ofthe sleeve.

FIGS. 13A-C and 14A-B illustrate an embodiment of a flexible, expandablestent comprising a window portion which may be selectively actuated topartially or totally occlude blood flow through the window portion.Stent 260 comprises a first end 262, a second end 264, and a stent wall266 which defines a lumen 268. A portion of the stent wall comprises awindow portion 270 defined by a first end 272, a second end 274, andfirst 276 and second 278 sides. As the stent is flexible and expandable,the window is expandable from a compact configuration as seen in FIG.13B to an expanded configuration as seen in FIGS. 13A and 13C. In thecompact configuration, the first and second sides are relatively closetogether and may touch or overlap, while in the expanded configurationthey are spaced apart from one another. Extending across the window fromthe first side 276 to the second side 278 are a plurality of flaps 280interposed with a plurality of vent openings 282. Each flap 280 maycomprise a first flap segment 284 and a second flap segment 286, coupledtogether by a hinge or pivot 288. In other embodiments, each flap maycomprise a unitary piece, similar to flap 119 in FIG. 12B. Because flaps280 comprise a pivot, the first and second flap segments may pivotrelative to one another about the pivot to increase or decrease thewidth of the window portion.

FIGS. 14A and 14B illustrate the window portion in more detail.Referring to FIG. 14A, in an open window configuration, the flaps aresubstantially orthogonal to the stent wall seen in FIG. 17C). Each flapsegment 288 has a first edge 290 and a second edge 292, which may definea top and bottom of the flap. An actuating mechanism comprising a tether294 may be connected to each flap segment 284, 286. The tethers may becollectively actuated to pivot the flap segments about their firstedges, moving the second edges along the direction of the arrows, totransform the window from the open window configuration seen in FIG. 14Aand FIG. 13C, to a closed window configuration seen in FIG. 14B, andvice versa. In the closed window configuration, the flaps have beenpivoted approximately 90° so that the first edge of one flap is adjacentto or overlies the first edge of the immediately adjacent flap,effectively closing the interposing vent 282. The tethers may beconnected to one another such that actuating a single tether oractuating mechanism pivots all the flaps, similar to opening and closingthe slats on a venetian blind by pulling a single cord, or collapsing arow of standing dominoes by touching one domino.

Referring again to FIG. 13A, stent 260 may be implanted in a vesseladjacent an aneurysm, with window 270 adjacent the aneurysm neck. Window270 may be opened to allow introduction of a coil or othervaso-occlusive device into the aneurysm, then closed, to preventmigration of the coil and prevent blood flow into the aneurysm. Thewindow 270 may further comprise a locking mechanism or fastening thatretains the window in the closed configuration. The window may be sizedand shaped to occupy only the portion of the stent wall that is adjacentthe aneurysm neck, and the remainder of the stent wall may allowunimpeded blood flow. Thus, any branching vessels near the aneurysm willnot be occluded when the window is closed.

Devices for intra-luminal occlusion of blood flow are illustrated inFIGS. 15A-15D and 16. Flow occlusion device 180 comprises a stentportion 182, expandable occlusion sheath 184, and an actuating portionwhich comprises a cable or drawstring 186. Stent portion 182 maycomprise a flexible, expandable stent, having a first end 188, a secondend 190 and a stent wall 192 defining a stent lumen 194. Attached to thefirst end 188 is the expandable occlusion sheath 184. Sheath 184 maycomprise a tubular portion of flexible, compliant material which maycomprise nylon, polyester, polyurethane, polyvinyl chloride, Teflon,ePTFE, PTFE, polyethylene, polypropylene, silicone, PEEK, and/orhydrogel, among others. The sheath may comprise mesh in which fibers areknitted, woven, braided, or otherwise intermeshed together. The sheath184 comprises a first end 196, a second end 198, and a sheath lumen 200defined by a sheath wall 202. A sheath orifice 204 is defined by thesecond end 198. The first end 196 of the sheath is attached to the firstend 188 of the stent, and in the open configuration illustrated in FIG.15B, the sheath lines a portion of the stent lumen 194 adjacent thefirst end 188 of the stent, with the second end 198 of the sheathoriented toward the second end 190 of the stent 182. The second end 198of the sheath slidingly engages the drawstring 186, which extendsthrough the stent lumen 194, such that a first end 187 of the drawstring186 lies outside the second end 190 of the stent 182.

As the drawstring first end 187 is pulled axially relative to the stent,the second end 198 of the sheath is drawn closed, gradually closing thesheath orifice 204. The sheath orifice 204 may be substantially circularin shape; as the second end 198 of the sheath is drawn closed, thediameter of the sheath orifice decreases.

To effect partial or complete occlusion of a blood vessel, flowocclusion device 180 may be implanted in the vessel at a desiredlocation. As long as the sheath orifice remains open, as in FIG. 15B,blood may flow freely through the vessel. Partial occlusion of thevessel may be accomplished by pulling the drawstring 186 to draw thesheath second end 198 partially closed, thus decreasing the size of thesheath orifice 204, as seen in FIG. 15C. If complete occlusion of thevessel is desired, drawstring 186 may be pulled to drawn the sheathsecond end entirely closed, thus closing the sheath orifice 204. Whenthe sheath orifice 204 is partially or completely closed, flow pressuremay cause the sheath may inflate or swell like a fluid filled parachuteor balloon, as seen in FIG. 15D. The flow occlusion device 180 may alsobe self-opening via a self-expanding ring in the sheath second end 198,which may be comprised of Nitinol, stainless steel, or any otherpreviously mentioned materials, such that the sheath orifice 204 isincreased in size in response to a relaxation of tension on thedrawstring 186. It is anticipated that the drawstring 186 would extendthrough the proximal vasculature and out of the body through a vascularport to a tie-off location or dial. This functionality allows theclinician to apply tension or remove tension over a period of time toadjustably control flow through the flow occlusion device 180 andperhaps allow collateral circulation to take develop in response to thevessel occlusion.

In an alternate embodiment of a flow occlusion device, the sheath 184and the drawstring 186 are not be positioned to extend back through thestent lumen 194 toward the stent second end 190, but instead extendaxially away from the first end 188 of the stent in the oppositedirection. See FIG. 16, which illustrates flow occlusion device 210 in amostly closed configuration.

In another alternate embodiment of a flow occlusion device, theocclusion sheath may be replaced with a plurality of sheets, membranousscales or plate-like members, connected to an actuating member. Theactuation member may be actuated to close the plate-like members aroundthe orifice, functioning similar to the iris of a camera lens togradually close the orifice, occluding blood flow.

Referring to FIGS. 17-18, devices for aneurysm treatment comprisingstent portions coupled with connection mesh portions are shown. In FIG.17A, aneurysm treatment device 220 comprises a first stent segment 222having a first end 224 and second end 226, second stent segment 228having a first end 230 and second end 232, and connection mesh 234having a first mesh end 236 and a second mesh end 238. The connectionmesh 234 is coupled to the first end 224 of the first stent segment 222,and the second end 232 of the second stent segment 228. The connectionmesh is sized and shaped to form a half-pipe or half-cylinder betweenthe two substantially cylindrical stent segments; and sized tocompletely bridge the neck of wide-necked aneurysm 8, the cutawayportion of which is indicated by a dashed line. The connection mesh isshown as attached to the stent segments at their ends; however in otherembodiments the connection mesh could overlap portions of one or bothstent segments. A coil 40 or other vaso-occlusive member may beintroduced into the aneurysm prior to or after placement of the device220, or the device may be used alone.

The connection mesh may comprise a portion of woven, knitted, braided,or otherwise intermeshed fibers. The fibers may comprise nylon, Nitinol,Dacron, polyester, polyurethane, polyvinyl chloride, Teflon, ePTFE,PTFE, polyethylene, polypropylene, silicone, PEEK, and/or hydrogel,among others. As seen in FIG. 17A, the mesh may form a half-cylinder of180°, or it may subtend an angle ranging from 30° to a full cylinder of360°, as shown in FIG. 17B illustrating an aneurysm treatment device 240comprising connection mesh 242.

Referring to FIG. 18, an aneurysm treatment device 250 may be placed tobridge the neck of a Y-junction vascular aneurysm, such as a basilar tipaneurysm 16. Device 250 comprises a first stent segment 252 and secondstent segment 254, connected by connection mesh 256. Connection mesh 256may be sized and shaped as a half-pipe or other partial cylinder, toprevent blood flow from entering the aneurysm and deflect blood flowthrough stent segments 252 and 254, as illustrated by arrows in FIG. 18.Optionally, a third stent segment 258 may be placed in the main vesselto reinforce it or encourage flow to divert into stent segments 252 and254 and away from aneurysm 16. A baffle may also be formed into theconnection mesh 256 to further divert blood flow into the branchingvessels and away from the aneurysm 16.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. For example,above are described various alternative examples of systems forproviding aneurysm treatment or vessel occlusion. It is appreciated thatvarious features of the above-described examples can be mixed andmatched to form a variety of other alternatives. For example, a barriermember or stent may be implanted with or without a vaso-occlusive coilor balloon. Variations in fenestration or cell opening sizes, shapes anddistribution may occur on inner sleeves and/or outer stents. Sleeves andstents can be juxtaposed in positional relationship or integrated intoone component. As such, the described embodiments are to be consideredin all respects only as illustrative and not restrictive. The scope ofthe invention is, therefore, indicated by the appended claims ratherthan by the foregoing description. All changes which come within themeaning and range of equivalency of the claims are to be embraced withintheir scope.

1. A system comprising: a flexible stent configured for placement in avessel, the stent comprising a first end and a second end and a stentwall extending therebetween defining a stent bore, the stent wallpermeable to blood flow, the stent wall comprising a plurality of stentcells; and an inner sleeve positioned inside and coaxial with theflexible stent, the inner sleeve comprising a first end and a second endand a sleeve wall extending therebetween defining a sleeve bore, thesleeve wall comprising a plurality of sleeve cells; wherein the stentand the sleeve comprise an open configuration wherein the sleeve cellsand the stent cells are aligned.
 2. The system of claim 1, wherein thestent and the sleeve comprise a closed configuration wherein the sleevecells and the stent cells are unaligned.
 3. The system of claim 2,wherein the sleeve rotates relative to the stent to transform the systembetween the open configuration and the closed configuration.
 4. Thesystem of claim 3, wherein when the system is in the open configurationthe sleeve cells and stent cells comprise a plurality of windows.
 5. Thesystem of claim 4, wherein the stent cells and sleeve cells are the sameshape and size.
 6. They system of claim 4, wherein the stent cells aredifferently shaped and sized than the sleeve cells.
 7. A systemcomprising: a flexible stent configured for placement in a parentvessel, the stent comprising a first end and a second end and a stentwall extending therebetween defining a stent bore, the stent wallpermeable to blood flow, the stent wall comprising a plurality of stentfenestrations, the stent further comprising a stent window located inthe stent wall; and an inner stent positioned inside and coaxial withthe flexible stent, the inner stent comprising a first end and a secondend and an inner stent wall extending therebetween defining an innerstent bore, the inner stent wall comprising a plurality of inner stentfenestrations.
 8. The system of claim 7, wherein the stent window islarger than the stent fenestrations.
 9. The system of claim 7, whereinthe inner stent further comprises an inner stent window located in theinner stent wall.
 10. The system of claim 9, wherein the inner stentwindow is larger than the inner stent fenestrations.
 11. The system ofclaim 10, wherein the system comprises a closed configuration in whichthe inner stent window is offset from the stent window so that noportion of the inner stent window overlaps the stent window.
 12. Thesystem of claim 11, wherein the system further comprises an openconfiguration in which the inner stent window is aligned with the stentwindow, forming an unimpeded opening through the stent wall and theinner stent wall.
 13. The system of claim 12, wherein the inner stentrotates relative to the stent to transform the system between the openconfiguration and the closed configuration.
 14. A system comprising: aflexible stent configured for placement in a vessel, the stentcomprising a first end and a second end and a stent wall extendingtherebetween defining a stent bore, the stent wall permeable to bloodflow, the stent wall comprising a plurality of stent cells, a stentwindow located in the stent wall; an inner sleeve positioned inside andcoaxial with the flexible stent, the inner sleeve comprising a first endand a second end and a sleeve wall extending therebetween defining asleeve bore, the sleeve wall comprising a plurality of sleeve cells, asleeve window located in the sleeve wall; wherein the system comprisesan open configuration in which the sleeve window is aligned with thestent window, forming an unimpeded opening through the stent wall andthe sleeve wall; and wherein the system comprises a closed configurationin which the sleeve window is offset from the stent window so that noportion of the sleeve window overlaps the stent window.
 15. The systemof claim 14, wherein the sleeve cells vary in size and distributionradially and along the length of the sleeve.
 16. The system of claim 14,wherein the sleeve cells are differently shaped and sized than the stentcells.
 17. The system of claim 14, wherein the sleeve cells are the sameshape and size as the stent cells.
 18. The system of claim 14, whereinthe sleeve rotates relative to the stent to transform the system betweenthe open configuration and the closed configuration.